DIA EUROPE 2021

This workshop will provide an overview of different imaging biomarkers and how they map into the different dimensions of therapeutic area, indication, trial phase and drug mechanism of action. It will explain how choices early in a drug development program can have an impact on time to market and development cost. We will also explore the fundamental difference between imaging used as a safety versus efficacy outcome. We will use an oncology drug development program as an example, explain how the FDA guidance on Clinical Trial Imaging Endpoint Process Standards impacts operational choices, discuss special considerations for basket trial designs and breakthrough therapies, and how the use of blinded independent review and investigator review can be balanced. We will then expand the concepts presented to illustrate options across a broader universe of therapeutic areas and imaging biomarkers, such as immunologic disorders, liver disease, central nervous system, lung disease and others. The objective is for workshop participants to identify how different imaging biomarkers and operational strategies should be chosen depending on the trial phase and trail design.